NCT01699737

Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Detailed description

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	JTT-851
DRUG	Glimepiride	Encapsulated Glimepiride tablets
DRUG	Placebo for Active
DRUG	Placebo for comparator

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-10-04
• Last updated: 2013-08-01

Locations

79 sites across 1 country: United States